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Channel: Medical Device Recalls since April 03, 2025
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Accelerated Care Plus Corporation - Omnicycle Elite - Class 2 Recall

Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment...

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SpineFrontier, Inc. - Screw Caddy, 8MM adn 9MMPedFuse - Class 2 Recall

Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw...

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Siemens Medical Solutions USA, Inc - syngo Dynamics - Class 2 Recall

syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical...

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Hospira Inc. - 1) Symbiq One Channel Infuser, 2) Symbiq Two Channel Infuser -...

The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous,...

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

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Acclarent, Inc. - Inspira AIR Balloon Dilation system - Class 2 Recall

Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

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Siemens Medical Solutions USA, Inc - Siemens Luminos dRF - Class 2 Recall

Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

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GE Healthcare, LLC - GE Healthcare, LOGIQ e Ultrasound System. - Class 2 Recall

GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow...

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Mesa Laboratories, Inc., Bozeman Manufacturing Facility - EZTest, Ensure,...

Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

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SpineFrontier, Inc. - SLIFT Slap Hammer - Class 2 Recall

S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to...

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Mesa Laboratories, Inc., Bozeman Manufacturing Facility - Mesa Labs, ETIGAM...

Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

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DePuy Orthopaedics, Inc. - Dovetail Intercalary component - Class 1 Recall

LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

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Precision Dynamics Corporation - Nonsterile Viscot Part Number 1437100...

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g.,...

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SpineFrontier, Inc. - Drill Guide (guide, surgical, instrument) - Class 2 Recall

Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while...

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Beckman Coulter Inc. - Beckman Coulter AU5800 Clinical Chemistry Analyzer -...

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality...

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